NCT04267029

Brief Summary

Transfusion reactions are defined as harms occurring during or after blood transfusion, with new heart/lung stress (eg. troubled breathing) regarded as cardiorespiratory transfusion reactions (CRTRs). CRTRs are among the most important, as the leading cause of transfusion-related harm and death. Though there are distinct classifications for these events, real life cases often don't fall neatly into a given category, with outliers regarded as "transfusion associated dyspnea (TAD)". It is unknown what TAD is -- whether it has a unique root cause, is a milder version of other known CRTRs, or is a blend of events. The purpose of this study is to better understand TAD and CRTRs by profiling them through a detailed medical history and more intensive laboratory assessment. This review of CRTRs may improve the quality/validity of final conclusions reported in the health record and to hemovigilance bodies, and uncover the nature of TAD and/or minimize CRTRs defaulting to the TAD category. Our enhanced understanding will advance diagnostic, treatment, and prevention efforts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

February 7, 2020

Last Update Submit

April 28, 2023

Conditions

Transfusion Reaction

Keywords

TACO (transfusion associated circulatory overload)TRALI (transfusion related acute lung injury)Allergic ReactionFNHTR (febrile non-hemolytic transfusion reaction)TAD (transfusion associated dyspnea)

Outcome Measures

Primary Outcomes (1)

  • CERTAINTY

    Improve certainty in final cardiorespiratory transfusion reaction event classifications (by reduction in the number of cases otherwise achieving no better than "possible" provisional conclusions), from the expected base ambiguity rate of 60%, down to 30%.

    2 years

Secondary Outcomes (2)

  • COMPLEXITY

    2 years

  • PATHOGENESIS FOOTPRINTING

    2 years

Study Arms (2)

Cases: CRTR (cardiorespiratory transfusion reaction)

Respiratory/cardiovascular disturbances after transfusion (\>/=2 of respiratory distress, pulmonary edema, cardiovascular system changes, fluid shifts, cardiac strain indicators), with or without accompanying (or pre-existing) fever

Diagnostic Test: TADPOL battery (deep clinicolaboratory profile)

Controls: HRFTR (high risk febrile transfusion reactions)

Post-transfusion fevers requiring laboratory investigation (Tmax\>/=39C, or lesser deflections if accompanied by chills/rigors), without respiratory features (hypoxia or dyspnea)

Diagnostic Test: TADPOL battery (deep clinicolaboratory profile)

Interventions

TADPOL battery (deep clinicolaboratory profile)DIAGNOSTIC_TEST

profile dimensions: * hemolytic * allergic * cardiorenal * inflammatory * leukoagglutinating * exploratory bioarchive

Cases: CRTR (cardiorespiratory transfusion reaction)Controls: HRFTR (high risk febrile transfusion reactions)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients at 4 university-affiliated teaching hospitals who have received a blood transfusion, and experienced a suspected acute transfusion reaction

You may qualify if:

  • Age ≥ 18 years
  • Transfusion of blood products (components or derivatives) with an available pre-transfusion group \& screen specimen
  • Referred to the blood transfusion laboratory for review of a suspected acute transfusion reaction (occurring within 24 hours of completing transfusion), and either exhibiting a cardiorespiratory disturbance (CRTR: cases) or a high-risk febrile disturbance (HRFTR: controls)

You may not qualify if:

  • Pregnant females
  • Massive hemorrhage entailing \>20 implicated products in the 24h period before the acute transfusion reaction's onset
  • Previous enrolment in the same designation (ie- an individual with RTR will not re-enroll if having another RTR, but may re-enrol if having FTR)
  • Expected to discharge home or die sooner than specimen acquisition
  • Withdrawal of consent at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (4)

  • Callum JL, Cohen R, Cressman AM, Strauss R, Armali C, Lin Y, Pendergrast J, Lieberman L, Scales DC, Skeate R, Ross H, Cserti-Gazdewich C. Cardiac stress biomarkers after red blood cell transfusion in patients at risk for transfusion-associated circulatory overload: a prospective observational study. Transfusion. 2018 Sep;58(9):2139-2148. doi: 10.1111/trf.14820.

    PMID: 30204946BACKGROUND

  • Cohen R, Escorcia A, Tasmin F, Lima A, Lin Y, Lieberman L, Pendergrast J, Callum J, Cserti-Gazdewich C. Feeling the burn: the significant burden of febrile nonhemolytic transfusion reactions. Transfusion. 2017 Jul;57(7):1674-1683. doi: 10.1111/trf.14099. Epub 2017 Mar 28.

    PMID: 28369916BACKGROUND

  • Parmar N, Pendergrast J, Lieberman L, Lin Y, Callum J, Cserti-Gazdewich C. The association of fever with transfusion-associated circulatory overload. Vox Sang. 2017 Jan;112(1):70-78. doi: 10.1111/vox.12473. Epub 2016 Dec 21.

    PMID: 28001310BACKGROUND

  • McVey MJ, Cohen R, Arsenault V, Escorcia A, Tasmin F, Pendergrast J, Lieberman L, Lin Y, Callum J, Cserti-Gazdewich C. Frequency and timing of all-cause deaths in visits involving suspected transfusion reactions, and the significance of cardiopulmonary disturbances. Vox Sang. 2021 Sep;116(8):898-909. doi: 10.1111/vox.13086. Epub 2021 Feb 26.

    PMID: 33634884BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Post-reaction plasma and serum and cellular pellets Implicated blood product residua

MeSH Terms

Conditions

Transfusion ReactionTransfusion-Related Acute Lung InjuryHypersensitivity

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesAcute Lung InjuryLung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christine M Csert-Gazdewich, MD

    Universith Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 12, 2020

Study Start

January 1, 2019

Primary Completion

October 4, 2022

Study Completion

December 22, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

CA(4)